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Ciclosporin

This factsheet has been written for members of the public by the UK Teratology Information Service (UKTIS). UKTIS is a not-for-profit organisation funded by Public Health England on behalf of UK Health Departments. UKTIS has been providing scientific information to health care providers since 1983 on the effects that medicines, recreational drugs and chemicals may have on the developing baby during pregnancy.

What is it?

Ciclosporin is a medicine that is prescribed to prevent and treat the rejection of a transplanted organ, and also to treat ulcerative colitis, rheumatoid arthritis, eczema, psoriasis, nephrotic syndrome (an illness caused by inflammation of the kidneys), and uveitis (inflammation of part of the eye). It works by suppressing the immune system and reducing inflammation in the body.

Is it safe to use ciclosporin in pregnancy?

There is no yes or no answer to this question. Any assessment of safety needs to weigh up the risks and benefits to both mother and baby of stopping a specific treatment against those of continuing the treatment. The outcome of this assessment will vary from person to person and will depend on the severity of the mother’s illness and the complications that could arise if her treatment is altered.

When deciding whether to use ciclosporin during pregnancy it is therefore important to weigh up how necessary it is to your health against any possible risks to you or your baby (summarised below), some of which might depend on how many weeks pregnant you are. Use of ciclosporin in pregnancy may be considered necessary to prevent the rejection of a transplanted organ or to treat a serious autoimmune or inflammatory illness.

You should not alter the dose of any of your medicines without medical supervision. Your doctor is the best person to help you decide what is right for you and your baby.

What if I have already used ciclosporin during pregnancy?

If you have taken any medicines it is always a good idea to let your doctor know that you are pregnant so that you can decide together whether you still need the medicines that you are on and, if so, to make sure that you are taking the lowest dose that works.

Can using ciclosporin in pregnancy cause my baby to be born with birth defects?

A baby’s body and most internal organs are formed during the first 12 weeks of pregnancy. It is mainly during this time that some medicines are known to cause birth defects.

Six studies have analysed how often birth defects occurred in a total of 575 babies born to women who used ciclosporin in early pregnancy. None of these studies found that use of ciclosporin in pregnancy increases the occurrence of birth defects in the baby. Although these results do not raise any concerns, not enough pregnancies have been studied to be able to identify whether ciclosporin use in early pregnancy might slightly increase the likelihood of a birth defect in the baby.

Can using ciclosporin in pregnancy cause miscarriage?

Studies that together include around 110 women using ciclosporin in early pregnancy have provided no evidence that use increases the risk of miscarriage. However, these studies did not use the most up-to-date statistical techniques and are based on relatively small numbers of pregnant women. Further larger studies that are designed to investigate this question are therefore required to confirm that ciclosporin use in pregnancy does not increase the likelihood of miscarriage.

Can using ciclosporin in pregnancy cause stillbirth?

Two small studies that together include 38 women using ciclosporin in pregnancy have provided no evidence that use increases the risk of stillbirth. However, because these findings are based on such a small number of women using ciclosporin, further larger studies are required before we can say whether use of ciclosporin in pregnancy might increase the risk of stillbirth.

Can using ciclosporin in pregnancy cause preterm birth?

It is unclear whether ciclosporin use in pregnancy increases the occurrence of preterm birth. Four controlled studies have investigated this question with different findings. The largest study (called a meta-analysis) included 379 women who used ciclosporin in pregnancy. This analysis found that preterm birth was much more common in babies of these women than in babies born to women with similar illnesses who were not taking ciclosporin. In none of the three remaining studies (which included a total of 99 pregnant women taking ciclosporin) was taking ciclosporin linked to a higher risk of giving birth prematurely. Although meta-analyses are regarded as one of the most reliable scientific approaches, it is uncertain whether women taking ciclosporin in this study had more severe illness than women who did not. If so, it is possible that delivery may have been induced early because of the mother’s poor health. Further research is therefore required to separate out the effects of ciclosporin treatment and the mother’s illness on pregnancy length.

Can using ciclosporin in pregnancy cause my baby to be smaller than normal at birth or to have a low birth weight (less than 2,500g)?

Seven studies of a total of 503 babies have investigated whether exposure to ciclosporin in the womb might affect the baby’s growth. Five of these studies found that babies exposed in pregnancy to ciclosporin were not at increased risk of having a low birth weight or of weighing less than expected for the week of pregnancy at which they were born. One of the two studies that showed a possible effect of ciclosporin use on a baby’s growth was not designed to take any possible effect of the mother’s illness on the baby’s growth in the womb into account. On balance, the studies that are currently available do not show that ciclosporin treatment in pregnancy increases the likelihood of the baby weighing less than expected at birth.

Can using ciclosporin in pregnancy cause learning and behavioural problems in the child?

A baby’s brain continues to develop throughout pregnancy. It is therefore possible that taking certain medicines at any stage of pregnancy could have a lasting effect on a child’s learning or behaviour.

Learning and behaviour has been studied in around 50 babies and children who were exposed to ciclosporin in the womb. Although there is currently no indication that exposure to ciclosporin in pregnancy is linked to learning and behavioural problems in the child, much larger studies that assess the many different aspects of learning and behaviour will be needed to confirm this.

Will my baby need extra monitoring during pregnancy or after delivery?

Most women will be offered a scan at around 20 weeks of pregnancy to look for birth defects as part of their routine antenatal care. Because some pregnancy outcomes have been studied in very few women using ciclosporin in pregnancy, your doctor may recommend additional monitoring. Women who have received an organ transplant, or who have certain autoimmune or inflammatory illnesses, will be more closely monitored anyway to ensure that their baby is growing and developing as expected.

Are there any risks to my baby if the father has used ciclosporin?

No studies have specifically investigated whether ciclosporin used by the father can harm the baby through effects on the sperm, however most experts agree that this is very unlikely. More research on the effects of medicine use in men around the time of conception is needed.

Who can I talk to if I have questions?

If you have any questions regarding the information in this leaflet please discuss them with your health care provider. They can access more detailed medical and scientific information from www.uktis.org.

General information

Up to 1 out of every 5 pregnancies ends in a miscarriage, and 1 in 40 babies are born with a birth defect. These are referred to as the background population risks. They describe the chance of these events happening for any pregnancy before taking factors such as the mother’s health during pregnancy, her lifestyle, medicines she takes and the genetic make up of her and the baby’s father into account.

Medicines use in pregnancy

Most medicines used by the mother will cross the placenta and reach the baby. Sometimes this may have beneficial effects for the baby. There are, however, some medicines that can harm a baby’s normal development. How a medicine affects a baby may depend on the stage of pregnancy when the medicine is taken. If you are on regular medication you should discuss these effects with your doctor/health care team before becoming pregnant.

If a new medicine is suggested for you during pregnancy, please ensure the doctor or health care professional treating you is aware of your pregnancy.

When deciding whether or not to use a medicine in pregnancy you need to weigh up how the medicine might improve your and/or your unborn baby’s health against any possible problems that the drug may cause. Our bumps leaflets are written to provide you with a summary of what is known about use of a specific medicine in pregnancy so that you can decide together with your health care provider what is best for you and your baby.

Every pregnancy is unique. The decision to start, stop, continue or change a prescribed medicine before or during pregnancy should be made in consultation with your health care provider.It is very helpful if you can record all your medication taken in pregnancy in your hand held maternity records.

www.medicinesinpregnancy.org

Disclaimer: This information is not intended to replace the individual care and advice of your health care provider. New information is continually becoming available. Whilst every effort will be made to ensure that this information is accurate and up to date at the time of publication, we cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes following decisions made on the basis of this information. We strongly advise that printouts should NOT be kept for any length of time, or for “future reference” as they can rapidly become out of date.